Project Summary/Abstract Tobacco products have been subject to relatively little regulation historically and remain a leading cause of cancer. Under the Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA), the Food and Drug Administration (FDA) is required to assess changes to regulated tobacco product packaging for impacts on population health. Thus, a product with a labeling change that makes it distinct from previous products is required to undergo a pre-market review process. There is little evidence, however, from the U.S. regulatory context about what constitutes a new product and which changes to a pack would matter. As public health regulators receive decreasing judicial deference while facing increased scrutiny from industry, regulations with a strong scientific foundation are critical to advance the FDA's mission. This research first investigates U.S. adult smoker perceptions of cigarette packaging changes using online, synchronous focus groups. The findings of these groups inform two experimental aims conducted with separate groups of U.S. adult smokers. In the first, a balanced incomplete block design (BIBD) and multidimensional scaling assess which changes to pack labeling identified in the qualitative aim are most associated with being a new, distinct product in the eyes of smokers. In the second, a BIBD is used to assess the influence of these labeling changes on cognitive and affective determinants of consumer behavior. This project uses a conceptual model from the product design literature that links visual packaging changes to consumer behavior. The implications of this research are important to the scientific evidence related to pre-market review. The ultimate goal of this research is to provide a scientific evidence base to prevent cancers and tobacco-related disease, disability, and death.